FDA Adverse Event
Summary report: N
BEAMPATH BP-LE
MDR report key: 2875280
·
Received November 23, 2012
Report
- Report Number
- 2875280
- Date Received
- November 23, 2012
- Date of Event
- November 19, 2012
- Report Date
- November 19, 2012
- Manufacturer
- OMNIGUIDE, INC.
- Product Code
- GEX
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
WHEN THE LASER WAS IN USE, THE LASER FIBER BLEW AND THEN DID NOT WORK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BEAMPATH BP-LE | POWERED LASER SURGICAL INSTRUMENT, CO2 LASER FIBER | GEX | OMNIGUIDE, INC. | BEAMPATH BP-LE | LA120925BA-P1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |